Personalized Smartphone-enabled Observational trial of Blood Pressure and its treatment during the SARS-CoV-2 COVID-19 Pandemic: A CURE-19 Study (Preprint)

Abstract

The use of digital interventions by patients for remote monitoring and management of health and disease is increasing. This observational study examined the deployment, feasibility, use and safety of a digital smartphone application for routine monitoring of blood pressure, medication and symptoms of COVID-19 during the COVID-19 pandemic.

The objective of this study was to deploy and test personalized electronic data recording in the form of a smartphone application in patients with primary hypertension for routine monitoring of blood pressure (BP) in a community setting within the United States of America (USA). We assessed patient onboarding to the smartphone application and autonomous patient engagement with data entry, focusing on daily BP measurement, BP medications and COVID-19 symptoms. We also assessed core interactions with the application as measured by adherence, acceptability and user experience over a period of 12 weeks. In addition, we examined clinical characteristics of the hypertensive population enrolled with a focus on BP control, concomitant BP drug use, emergent symptoms indicative of SARS-CoV-2 infection and safety of the participants relating to the use of the application.

This remote decentralized 12-week prospective observational study was conducted in the community with no participant visits to investigational sites. Participants were asked to download the digital application to their smartphone. Following enrollment, participants were asked to record daily BP, associated medication use, and emergent symptoms associated with SARS-CoV-2 infection into the application. Adverse event data relating to the use of the application was also collected. Engagement with the application was assessed by examination of routine data entry rates throughout the observation period. Feasibility and participant feedback was assessed upon study completion using the User Experience Questionnaire (UEQ).

The smartphone application was rapidly and successfully deployed into a community setting within the USA. Of the 389 participants enrolled in the study, 380 participants (98%) downloaded and entered BP routines in Week 1. Application engagement remained high; 239 participants remained in the study for the full 12 week observation period, 84.1% entered full BP routines into the digital application 80% or more of the time. The smartphone application scored an overall positive evaluation as assessed by the UEQ and was benchmarked ‘Excellent’ for domains of perspicuity, efficiency, and dependability and ‘Above Average’ for domains of attractiveness and stimulation. Highly adherent hypertensive participants demonstrated well controlled BP, with no significant changes in average systolic or diastolic BP between Week 1 and Week 12. Participants were able to record BP medications and symptoms of SARS-CoV-2 infection. No adverse events attributable to use of the smartphone application were reported during the observational period.

The high retention, engagement, acceptability and positive feedback in this study demonstrates routine monitoring of BP and medications utilizing a smartphone application is feasible for hypertensive patients in a community setting. This remote monitoring of blood pressure and data collection could be coupled with hypertensive medication in a combination product (drug + digital) for precision management of hypertension.